Ethics are sometimes a victim in the big business of good medicine, writes Ruth Pollard.

IT BRINGS a wry smile to people’s faces to hear that two drug companies made it into the top 10 most ethical companies in the world. Most of us benefit from medications developed by these multinationals, but we deeply distrust their methods. Old drugs are repackaged for new conditions, generic medicines are opposed, negative research results are withheld and developing countries are forced to pay crippling fees as part of deeply unfair medication pricing structures.

In September 2004 the blockbuster anti-inflammatory Vioxx was suddenly withdrawn from the market by its manufacturer, Merck & Co, after it emerged that the drug increased the risk of heart attack and stroke. At the time 250,000 to 300,000 Australians were taking the drug to treat the symptoms of arthritis. The company is facing more than 14,000 lawsuits in the US and a class action in Australia. The Medical Journal of Australia estimates that Vioxx caused “several thousand” premature heart attacks in this country and up to 300 deaths.

It soon emerged that Merck had either misrepresented or failed to disclose the health risks associated with the drug and that its highly effective public relations machine had capitalised on a generally uncritical medical profession.

Merck was not one of the companies that made it into the world’s top 10 ethical companies on the Geneva-based Covalence reputation index. Set up to provide a “barometer of how multinationals are perceived in the ethical field”, the index classifies companies according to 45 criteria of business contribution to human development, including labour standards, waste management, the social utility of products and human rights policy.

Jon Jureidini is the head of psychological medicine at Adelaide’s Women’s and Children’s Hospital, and the chairman of Healthy Skepticism, a website that exposes pharmaceutical company marketing techniques. He is deeply critical of Glaxo’s failure to warn doctors and consumers about the potentially negative side effects of its anti-depressant Aropax/Paxil on children – a charge the drug company strenuously denies.

“There is all kinds of litigation happening in relation to antidepressants and children. There are a couple of class actions taking them to task for misrepresenting data and for fraudulent sales,” Jureidini says. “GSK has made mileage out of the fact that they have published two negative studies on the effects on children, but what they don’t say is that they had to do that as part of another settlement.”

That settlement was the result of a lawsuit filed by the then New York attorney-general and now Governor, Eliot Spitzer, that alleged Glaxo suppressed four studies which failed to demonstrate the drug was effective in children and adolescents and pointed to a possible increase in suicidal thinking and actions.

The drug company settled for $3.54 million and agreed to publish all clinical results, so discrepancies between its marketing and its clinical results could be detected.

It is easy to learn the rules and give the impression you are behaving ethically, says Jureidini. “That also depends on the methodology you use to assess ethics … you might have a view that if 95 per cent of what a company does is ethical then it is an ethical company. Merck had a very high reputation … of being a very ethical company until Vioxx.”

While the rewards for creating and marketing a blockbuster drug are in the billions of dollars, people with an ethical voice in an organisation are going to be drowned out by those with their eye on profits, he says.

“GSK is being hailed as an ethical company and I am sitting here working on a draft of a paper about their behaviour in relation to the study they publicised saying that Aropax/Paxil was safe and effective for children, whereas in fact the study showed just the opposite,” Jureidini says.

The rule of thumb, he says, is: studies that don’t look good don’t, in general, get published; when they do they are reported selectively. As well, pharmaceutical companies “own and maintain key opinion leaders” and control the continuing medical education of doctors and specialists.

Donations by drug companies to patient self-help and advocacy groups are almost certain to score brownie points on an ethical measure. But many activists see such donations as covert marketing, making these groups advocates for a disease that suits their product, Jureidini says.

Open the medicine cabinet in any house and you will find evidence of the good pharmaceutical companies do, from painkillers to antibiotics to heart medication. Epidemics of measles, smallpox, chickenpox, whooping cough, polio and other communicable diseases have been stopped – in the developing world at least – by drug company investments in the creation of safe and effective vaccines and the government programs that distribute them.

“They plainly have credentials to put them on the side of the angels,” says Simon Chapman, a professor in public health at the University of Sydney. “If you look at the contribution of the pharmaceutical industry in the development of medicine they are right up there – vaccines, antibiotics, oral rehydration therapies, chronic disease control.”

The trouble starts when the drive to do good is clouded by the inevitable profit motive, Chapman says. “Pharmaceutical pricing, standing in the way of generics which will bring immense population benefits … make it a very fraught issue.”

And while a lot of the bad press the pharmaceutical companies attract is deserved, it would be unimaginable to have the industry disappear. “It is a trade-off between the undoubted benefits that pharmaceutical research and development brings to world health, and the critics who say sucking those sorts of profits out of countries is unacceptable.”

Chapman says developments in pain medication alone have immeasurably improved people’s lives. He points to the publication last month in the British Medical Journal of the 15 most important medical advances since 1840. Sanitation and clean water supplies came in at No. 1, followed closely by the development of antibiotics, anaesthesia, vaccines, the discovery of DNA structure and the oral contraceptive pill. Pharmaceutical companies were intimately involved in the development of most of the top 15, he says.

But there are areas of extreme neglect – forgotten diseases that threaten millions in developing countries each year and for which there are only decades-old, ineffective or dangerous treatments.

Sleeping sickness, leishmaniasis and Chagas disease, along with malaria, tuberculosis and HIV, account for 90 per cent of the world’s disease burden, yet attract just 10 per cent of health research efforts, says the aid group Medecins Sans Frontieres.

One of the final frontiers in providing access to safe, effective and affordable medicines are generic brands. MSF is fighting the pharmaceutical company Novartis, which has taken on the Indian Government to try to force changes to its patent laws. “If Novartis wins, a major source of affordable medicines for millions of people across the globe could dry up,” MSF says.

Medicines Australia, the pharmaceutical industry self-regulator with drug companies as its members, was quick to congratulate GlaxoSmithKline and Bristol-Myers Squibb on gaining “significant international recognition” for their work. “This is indicative of the pharmaceutical industry as a whole and reflects the value and contribution of the industry to society,” Medicines Australia’s chief executive, Ian Chalmers, said.

Yet only 18 months ago, the Medical Journal of Australia published a study that found the publication of incomplete or biased pharmaceutical trials is common. Interference was most blatant when the research showed potentially negative effects of a drug or treatment, it found.

Results like this confirm that despite their contribution to the health of people in the world, drug companies have a way to go before they achieve an “A” for ethics.

Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963

Our main aim is improving health by reducing harm from misleading health information.
We are an international non-profit membership association incorporated in South Australia: A8764, ABN 43 390 138 359.
Everyone who supports our aims is welcome to join us.